Pub Date : 2024-06-17DOI: 10.1136/rmdopen-2024-004281
Keigo Hayashi, Gregory C McDermott, Pierre-Antoine Juge, Matthew Moll, Michael H Cho, Xiaosong Wang, Misti L Paudel, Tracy J Doyle, Gregory L Kinney, Danielle Sansone-Poe, Kendra Young, Paul F Dellaripa, Zachary S Wallace, Elizabeth A Regan, Gary M Hunninghake, Edwin K Silverman, Samuel Y Ash, Raul San Jose Estepar, George R Washko, Jeffrey A Sparks
Objective: To compare longitudinal changes in spirometric measures between patients with rheumatoid arthritis (RA) and non-RA comparators.
Methods: We analysed longitudinal data from two prospective cohorts: the UK Biobank and COPDGene. Spirometry was conducted at baseline and a second visit after 5-7 years. RA was identified based on self-report and disease-modifying antirheumatic drug use; non-RA comparators reported neither. The primary outcomes were annual changes in the per cent-predicted forced expiratory volume in 1 s (FEV1%) and per cent predicted forced vital capacity (FVC%). Statistical comparisons were performed using multivariable linear regression. The analysis was stratified based on baseline smoking status and the presence of obstructive pattern (FEV1/FVC <0.7).
Results: Among participants who underwent baseline and follow-up spirometry, we identified 233 patients with RA and 37 735 non-RA comparators. Among never-smoking participants without an obstructive pattern, RA was significantly associated with more FEV1% decline (β=-0.49, p=0.04). However, in ever smokers with ≥10 pack-years, those with RA exhibited significantly less FEV1% decline than non-RA comparators (β=0.50, p=0.02). This difference was more pronounced among those with an obstructive pattern at baseline (β=1.12, p=0.01). Results were similar for FEV1/FVC decline. No difference was observed in the annual FVC% change in RA versus non-RA.
Conclusions: Smokers with RA, especially those with baseline obstructive spirometric patterns, experienced lower FEV1% and FEV1/FVC decline than non-RA comparators. Conversely, never smokers with RA had more FEV1% decline than non-RA comparators. Future studies should investigate potential treatments and the pathogenesis of obstructive lung diseases in smokers with RA.
目的比较类风湿性关节炎(RA)患者与非类风湿性关节炎比较者肺活量的纵向变化:我们分析了英国生物库和 COPDGene 这两个前瞻性队列的纵向数据。在基线和 5-7 年后的第二次访问中进行了肺活量测定。根据自我报告和使用改变病情抗风湿药物的情况确定是否患有 RA;非 RA 的比较者既不报告也不报告。主要结果是预测的 1 秒用力呼气容积百分比(FEV1%)和预测的用力肺活量百分比(FVC%)的年度变化。统计比较采用多变量线性回归法。根据基线吸烟状况和是否存在阻塞模式(FEV1/FVC 结果)进行了分层分析:在接受基线和随访肺活量测定的参与者中,我们发现了 233 名 RA 患者和 37 735 名非 RA 对比者。在没有阻塞模式的从不吸烟者中,RA 与更多的 FEV1% 下降显著相关(β=-0.49,p=0.04)。然而,在吸烟≥10 包年的吸烟者中,RA 患者的 FEV1% 下降率明显低于非 RA 比较者(β=0.50,P=0.02)。这种差异在基线阻塞型患者中更为明显(β=1.12,p=0.01)。FEV1/FVC 下降的结果类似。在每年的 FVC% 变化中,RA 与非 RA 没有差异:结论:患有 RA 的吸烟者,尤其是基线阻塞性肺活量模式的吸烟者,其 FEV1% 和 FEV1/FVC 下降率低于非 RA 比较者。相反,从未吸烟的 RA 患者的 FEV1% 下降幅度高于非 RA 对比者。未来的研究应探讨潜在的治疗方法以及RA吸烟者阻塞性肺部疾病的发病机制。
{"title":"Rheumatoid arthritis and changes on spirometry by smoking status in two prospective longitudinal cohorts.","authors":"Keigo Hayashi, Gregory C McDermott, Pierre-Antoine Juge, Matthew Moll, Michael H Cho, Xiaosong Wang, Misti L Paudel, Tracy J Doyle, Gregory L Kinney, Danielle Sansone-Poe, Kendra Young, Paul F Dellaripa, Zachary S Wallace, Elizabeth A Regan, Gary M Hunninghake, Edwin K Silverman, Samuel Y Ash, Raul San Jose Estepar, George R Washko, Jeffrey A Sparks","doi":"10.1136/rmdopen-2024-004281","DOIUrl":"10.1136/rmdopen-2024-004281","url":null,"abstract":"<p><strong>Objective: </strong>To compare longitudinal changes in spirometric measures between patients with rheumatoid arthritis (RA) and non-RA comparators.</p><p><strong>Methods: </strong>We analysed longitudinal data from two prospective cohorts: the UK Biobank and COPDGene. Spirometry was conducted at baseline and a second visit after 5-7 years. RA was identified based on self-report and disease-modifying antirheumatic drug use; non-RA comparators reported neither. The primary outcomes were annual changes in the per cent-predicted forced expiratory volume in 1 s (FEV<sub>1</sub>%) and per cent predicted forced vital capacity (FVC%). Statistical comparisons were performed using multivariable linear regression. The analysis was stratified based on baseline smoking status and the presence of obstructive pattern (FEV<sub>1</sub>/FVC <0.7).</p><p><strong>Results: </strong>Among participants who underwent baseline and follow-up spirometry, we identified 233 patients with RA and 37 735 non-RA comparators. Among never-smoking participants without an obstructive pattern, RA was significantly associated with more FEV<sub>1</sub>% decline (β=-0.49, p=0.04). However, in ever smokers with ≥10 pack-years, those with RA exhibited significantly less FEV<sub>1</sub>% decline than non-RA comparators (β=0.50, p=0.02). This difference was more pronounced among those with an obstructive pattern at baseline (β=1.12, p=0.01). Results were similar for FEV<sub>1</sub>/FVC decline. No difference was observed in the annual FVC% change in RA versus non-RA.</p><p><strong>Conclusions: </strong>Smokers with RA, especially those with baseline obstructive spirometric patterns, experienced lower FEV<sub>1</sub>% and FEV<sub>1</sub>/FVC decline than non-RA comparators. Conversely, never smokers with RA had more FEV<sub>1</sub>% decline than non-RA comparators. Future studies should investigate potential treatments and the pathogenesis of obstructive lung diseases in smokers with RA.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: The tuning effects of JAK/TYK2 inhibitors on the imbalance between T follicular helper (Tfh) and T regulatory (Treg) cells, related to systemic lupus erythematosus (SLE) pathogenesis, were investigated using human peripheral blood samples.
Methods: Peripheral blood mononuclear cells from untreated patients with SLE and healthy controls were analysed. Tfh1 cells were identified in nephritis tissue, and the effect of Tfh1 cells on B-cell differentiation was examined by coculturing naïve B cells with Tfh1 cells.
Results: Tfh1 cell numbers were increased in the peripheral blood of patients, and activated Treg cell counts were decreased relative to Tfh1 cell counts. This imbalance in the Tfh to Treg ratio was remarkably pronounced in cases of lupus nephritis, especially in types III and IV active nephritis. Immunohistochemistry revealed Tfh1 cell infiltration in lupus nephritis tissues. Co-culture of Tfh1 cells (isolated from healthy individuals) with naïve B cells elicited greater induction of T-bet+ B cells than controls. In JAK/TYK2-dependent STAT phosphorylation assays using memory CD4+ T cells, IL-12-induced STAT1/4 phosphorylation and Tfh1 cell differentiation were inhibited by both JAK and TYK2 inhibitors. However, phosphorylation of STAT5 by IL-2 and induction of Treg cell differentiation by IL-2+TGFβ were inhibited by JAK inhibitors but not by TYK2 inhibitors, suggesting that TYK2 does not mediate the IL-2 signalling pathway.
Conclusions: Tfh1 cells can induce T-bet+ B cell production and may contribute to SLE pathogenesis-associated processes. TYK2 inhibitor may fine-tune the immune imbalance by suppressing Tfh1 differentiation and maintaining Treg cell differentiation, thereby preserving IL-2 signalling, unlike other JAK inhibitors.
研究目的使用人体外周血样本研究了 JAK/TYK2 抑制剂对与系统性红斑狼疮(SLE)发病机制有关的 T 滤泡辅助细胞(Tfh)和 T 调节细胞(Treg)失衡的调节作用:方法:分析了未经治疗的系统性红斑狼疮患者和健康对照组的外周血单核细胞。方法:分析未经治疗的系统性红斑狼疮患者和健康对照组的外周血单核细胞,在肾炎组织中鉴定出 Tfh1 细胞,并通过将幼稚 B 细胞与 Tfh1 细胞共培养,研究 Tfh1 细胞对 B 细胞分化的影响:结果:患者外周血中的Tfh1细胞数量增加,而活化的Treg细胞数量相对于Tfh1细胞数量减少。在狼疮肾炎病例中,尤其是在 III 型和 IV 型活动性肾炎病例中,Tfh 与 Treg 的比例失衡现象非常明显。免疫组化显示狼疮肾炎组织中有 Tfh1 细胞浸润。与对照组相比,Tfh1细胞(从健康人体内分离)与幼稚B细胞共培养可诱导出更多的T-bet+ B细胞。在使用记忆CD4+ T细胞进行的JAK/TYK2依赖性STAT磷酸化试验中,JAK和TYK2抑制剂都抑制了IL-12诱导的STAT1/4磷酸化和Tfh1细胞分化。然而,JAK抑制剂抑制了IL-2诱导的STAT5磷酸化和IL-2+TGFβ诱导的Treg细胞分化,但TYK2抑制剂却没有抑制STAT5磷酸化和Treg细胞分化,这表明TYK2并不介导IL-2信号通路:结论:Tfh1细胞可诱导T-bet+ B细胞生成,并可能对系统性红斑狼疮发病机制相关过程做出贡献。与其他 JAK 抑制剂不同的是,TYK2 抑制剂可通过抑制 Tfh1 分化和维持 Treg 细胞分化来微调免疫失衡,从而保留 IL-2 信号。
{"title":"Modifying T cell phenotypes using TYK2 inhibitor and its implications for the treatment of systemic lupus erythematosus.","authors":"Yurie Satoh-Kanda, Shingo Nakayamada, Satoshi Kubo, Kaoru Yamagata, Aya Nawata, Hiroaki Tanaka, Shunpei Kosaka, Ryuichiro Kanda, Shan Yu, Yuya Fujita, Koshiro Sonomoto, Yoshiya Tanaka","doi":"10.1136/rmdopen-2023-003991","DOIUrl":"10.1136/rmdopen-2023-003991","url":null,"abstract":"<p><strong>Objectives: </strong>The tuning effects of JAK/TYK2 inhibitors on the imbalance between T follicular helper (Tfh) and T regulatory (Treg) cells, related to systemic lupus erythematosus (SLE) pathogenesis, were investigated using human peripheral blood samples.</p><p><strong>Methods: </strong>Peripheral blood mononuclear cells from untreated patients with SLE and healthy controls were analysed. Tfh1 cells were identified in nephritis tissue, and the effect of Tfh1 cells on B-cell differentiation was examined by coculturing naïve B cells with Tfh1 cells.</p><p><strong>Results: </strong>Tfh1 cell numbers were increased in the peripheral blood of patients, and activated Treg cell counts were decreased relative to Tfh1 cell counts. This imbalance in the Tfh to Treg ratio was remarkably pronounced in cases of lupus nephritis, especially in types III and IV active nephritis. Immunohistochemistry revealed Tfh1 cell infiltration in lupus nephritis tissues. Co-culture of Tfh1 cells (isolated from healthy individuals) with naïve B cells elicited greater induction of T-bet<sup>+</sup> B cells than controls. In JAK/TYK2-dependent STAT phosphorylation assays using memory CD4<sup>+</sup> T cells, IL-12-induced STAT1/4 phosphorylation and Tfh1 cell differentiation were inhibited by both JAK and TYK2 inhibitors. However, phosphorylation of STAT5 by IL-2 and induction of Treg cell differentiation by IL-2+TGFβ were inhibited by JAK inhibitors but not by TYK2 inhibitors, suggesting that TYK2 does not mediate the IL-2 signalling pathway.</p><p><strong>Conclusions: </strong>Tfh1 cells can induce T-bet<sup>+</sup> B cell production and may contribute to SLE pathogenesis-associated processes. TYK2 inhibitor may fine-tune the immune imbalance by suppressing Tfh1 differentiation and maintaining Treg cell differentiation, thereby preserving IL-2 signalling, unlike other JAK inhibitors.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-12DOI: 10.1136/rmdopen-2024-004177
Pierre-Antoine Juge, Tue Wenzel Kragstrup, Luis Fernando Perez-Garcia, Elsa Frãzao-Mateus, Souzi Makri, Peter Boyd, Jette Primdahl, Ricardo J O Ferreira, Theodora P M Vliet Vlieland, Mwidimi Ndosi, Uta Kiltz, Robert Landewé, Kim Lauper, Manouk de Hooge
Objective: European Alliance of Associations for Rheumatology (EULAR) task forces (TF) requires participation of ≥2 junior members, a health professional in rheumatology (HPR) and two patient research partners for the development of recommendations or points to consider. In this study, participation of these junior and representative members was compared with the one of traditional TF members (convenor, methodologist, fellow and expert TF members).
Methods: An online survey was developed and emailed to previous EULAR TF members. The survey comprised multiple-choice, open-ended and 0-100 rating scale (fully disagree to fully agree) questions.
Results: In total, 77 responded, 48 (62%) women. In total, 46 (60%) had participated as a junior or representative TF member. Most junior/representative members reported they felt unprepared for their first TF (10/14, 71%). Compared with traditional members, junior/representative members expressed a significantly higher level of uncertainty about their roles within the TF (median score 23 (IQR 7.0-52.0) vs 7 (IQR 0.0-21.0)), and junior/representative members felt less engaged by the convenor (54% vs 71%). Primary factors that facilitated interaction within a TF were experience, expertise and preparation (54%), a supportive atmosphere (42%) and a clear role (12%).
Conclusion: Juniors, patients and HPR experience various challenges when participating in a EULAR TF. These challenges differ from and are generally less pronounced than those experienced by traditional TF members. The convenor should introduce the participants to the tasks, emphasise the value of their contributions and how to prepare accordingly for the TF meeting.
{"title":"Evaluating the participation of junior members and patient and healthcare professionals representatives in EULAR task forces: results from an international survey.","authors":"Pierre-Antoine Juge, Tue Wenzel Kragstrup, Luis Fernando Perez-Garcia, Elsa Frãzao-Mateus, Souzi Makri, Peter Boyd, Jette Primdahl, Ricardo J O Ferreira, Theodora P M Vliet Vlieland, Mwidimi Ndosi, Uta Kiltz, Robert Landewé, Kim Lauper, Manouk de Hooge","doi":"10.1136/rmdopen-2024-004177","DOIUrl":"10.1136/rmdopen-2024-004177","url":null,"abstract":"<p><strong>Objective: </strong>European Alliance of Associations for Rheumatology (EULAR) task forces (TF) requires participation of ≥2 junior members, a health professional in rheumatology (HPR) and two patient research partners for the development of recommendations or points to consider. In this study, participation of these junior and representative members was compared with the one of traditional TF members (convenor, methodologist, fellow and expert TF members).</p><p><strong>Methods: </strong>An online survey was developed and emailed to previous EULAR TF members. The survey comprised multiple-choice, open-ended and 0-100 rating scale (fully disagree to fully agree) questions.</p><p><strong>Results: </strong>In total, 77 responded, 48 (62%) women. In total, 46 (60%) had participated as a junior or representative TF member. Most junior/representative members reported they felt unprepared for their first TF (10/14, 71%). Compared with traditional members, junior/representative members expressed a significantly higher level of uncertainty about their roles within the TF (median score 23 (IQR 7.0-52.0) vs 7 (IQR 0.0-21.0)), and junior/representative members felt less engaged by the convenor (54% vs 71%). Primary factors that facilitated interaction within a TF were experience, expertise and preparation (54%), a supportive atmosphere (42%) and a clear role (12%).</p><p><strong>Conclusion: </strong>Juniors, patients and HPR experience various challenges when participating in a EULAR TF. These challenges differ from and are generally less pronounced than those experienced by traditional TF members. The convenor should introduce the participants to the tasks, emphasise the value of their contributions and how to prepare accordingly for the TF meeting.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141311602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-12DOI: 10.1136/rmdopen-2024-004218
Marco Garrido-Cumbrera, Victoria Navarro-Compán, Denis Poddubnyy, Fernando Sommerfleck, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Christine Bundy
Background: This study aims to assess the prevalence of poor mental health in axial spondyloarthritis (axSpA) and its associated factors in a large sample of patients from the International Map of Axial Spondyloarthritis (IMAS) study from around the globe.
Methods: IMAS is a cross-sectional online survey (2017-2022) that includes 5557 unselected patients with axSpA worldwide. Mental health was evaluated by the 12-item General Health Questionnaire (GHQ-12) and the cut-off point for poor mental health was set at 3. Logistic regression analysis was used to evaluate relationships between the investigated factors and poor mental health (GHQ-12≥3) in patients with axSpA (n=4335).
Results: Of 5351 patients, the mean of GHQ-12 was 4.7 and 59.4% were having poor mental health, being 69.9% in South Africa, 63.7% in Latin America, 60.8% in Europe, 54.3% in North America and 51.8% in Asia. Overall, 40.5% and 37.2% of patients experienced anxiety and depression. The factors associated with poor mental health were younger age (OR=0.99), female gender (OR=1.16), being on sick leave or unemployed (OR=1.63), non-physical activity (OR=1.22), smoking (OR=1.20), higher Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] (OR=1.42), functional limitation (OR=1.02) and shorter symptoms duration (OR=0.98).
Conclusions: Globally, 6 in 10 patients with axSpA had poor mental health, with a higher proportion in South Africa and lower in Asia. The factors associated with poor mental health include domains such as younger age, female gender, employment difficulties, harmful habits, disease burden and symptom duration. A holistic management approach to axSpA should encompass both physical and mental health.
{"title":"Factors Associated with Poor Mental Health in Patients with Axial Spondyloarthritis: Results from the International Map of Axial Spondyloarthritis (IMAS).","authors":"Marco Garrido-Cumbrera, Victoria Navarro-Compán, Denis Poddubnyy, Fernando Sommerfleck, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Christine Bundy","doi":"10.1136/rmdopen-2024-004218","DOIUrl":"10.1136/rmdopen-2024-004218","url":null,"abstract":"<p><strong>Background: </strong>This study aims to assess the prevalence of poor mental health in axial spondyloarthritis (axSpA) and its associated factors in a large sample of patients from the International Map of Axial Spondyloarthritis (IMAS) study from around the globe.</p><p><strong>Methods: </strong>IMAS is a cross-sectional online survey (2017-2022) that includes 5557 unselected patients with axSpA worldwide. Mental health was evaluated by the 12-item General Health Questionnaire (GHQ-12) and the cut-off point for poor mental health was set at 3. Logistic regression analysis was used to evaluate relationships between the investigated factors and poor mental health (GHQ-12≥3) in patients with axSpA (n=4335).</p><p><strong>Results: </strong>Of 5351 patients, the mean of GHQ-12 was 4.7 and 59.4% were having poor mental health, being 69.9% in South Africa, 63.7% in Latin America, 60.8% in Europe, 54.3% in North America and 51.8% in Asia. Overall, 40.5% and 37.2% of patients experienced anxiety and depression. The factors associated with poor mental health were younger age (OR=0.99), female gender (OR=1.16), being on sick leave or unemployed (OR=1.63), non-physical activity (OR=1.22), smoking (OR=1.20), higher Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] (OR=1.42), functional limitation (OR=1.02) and shorter symptoms duration (OR=0.98).</p><p><strong>Conclusions: </strong>Globally, 6 in 10 patients with axSpA had poor mental health, with a higher proportion in South Africa and lower in Asia. The factors associated with poor mental health include domains such as younger age, female gender, employment difficulties, harmful habits, disease burden and symptom duration. A holistic management approach to axSpA should encompass both physical and mental health.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141311603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: To investigate the early detection of pulmonary non-tuberculous mycobacterial (PNTM) disease by CT before the initiation of molecular-targeted therapeutic drugs in patients with rheumatoid arthritis (RA) and the efficacy and safety of combined treatment with antibiotics.
Methods: Patients with RA underwent chest CT before the introduction of molecular-targeted therapies in the Further Improvement of Rheumatoid arthritis Treatment registry. The primary endpoint was the number of patients who were detected by CT as having PNTM disease, complicating RA.
Results: Of 4447 patients with RA who underwent chest CT, 107 had suspected PNTM disease, and 33 diagnoses were confirmed by culture. In 14 of the 33 patients, plain radiographs showed no abnormalities; PNTM disease was only observed on CT scans. The prevalence of PNTM disease in patients with RA requiring molecular-targeted treatment was six times higher than that in healthy individuals. 31 patients initiated molecular-targeted therapeutic drugs in combination with anti-NTM treatment, and 28 were followed up for 24 months. No significant difference was observed in the retention rate and RA disease activity at 24 months between the PNTM and non-PNTM groups. Coexisting PNTM disease did not affect treatment discontinuation. None of the 28 patients in the PNTM group experienced exacerbation of PNTM disease.
Conclusion: CT screening before the initiation of molecular-targeted treatment enabled the detection of asymptomatic PNTM that was undetectable on plain radiographs. This study showed that molecular-targeted therapeutic drugs in combination with anti-NTM treatment could control the disease activity of both PNTM and RA.
{"title":"CT informs detection and treatment options in rheumatoid arthritis complicated by pulmonary non-tuberculous mycobacterial disease from the FIRST registry.","authors":"Masashi Funada, Yusuke Miyazaki, Shingo Nakayamada, Koshiro Sonomoto, Satoshi Kubo, Ippei Miyagawa, Hiroaki Tanaka, Yoshiya Tanaka","doi":"10.1136/rmdopen-2023-004049","DOIUrl":"10.1136/rmdopen-2023-004049","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the early detection of pulmonary non-tuberculous mycobacterial (PNTM) disease by CT before the initiation of molecular-targeted therapeutic drugs in patients with rheumatoid arthritis (RA) and the efficacy and safety of combined treatment with antibiotics.</p><p><strong>Methods: </strong>Patients with RA underwent chest CT before the introduction of molecular-targeted therapies in the Further Improvement of Rheumatoid arthritis Treatment registry. The primary endpoint was the number of patients who were detected by CT as having PNTM disease, complicating RA.</p><p><strong>Results: </strong>Of 4447 patients with RA who underwent chest CT, 107 had suspected PNTM disease, and 33 diagnoses were confirmed by culture. In 14 of the 33 patients, plain radiographs showed no abnormalities; PNTM disease was only observed on CT scans. The prevalence of PNTM disease in patients with RA requiring molecular-targeted treatment was six times higher than that in healthy individuals. 31 patients initiated molecular-targeted therapeutic drugs in combination with anti-NTM treatment, and 28 were followed up for 24 months. No significant difference was observed in the retention rate and RA disease activity at 24 months between the PNTM and non-PNTM groups. Coexisting PNTM disease did not affect treatment discontinuation. None of the 28 patients in the PNTM group experienced exacerbation of PNTM disease.</p><p><strong>Conclusion: </strong>CT screening before the initiation of molecular-targeted treatment enabled the detection of asymptomatic PNTM that was undetectable on plain radiographs. This study showed that molecular-targeted therapeutic drugs in combination with anti-NTM treatment could control the disease activity of both PNTM and RA.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141311601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-11DOI: 10.1136/rmdopen-2024-004208
Jos Runhaar, Ömer Özbulut, Margreet Kloppenburg, Maarten Boers, Johannes W J Bijlsma, Sita Bierma-Zeinstra
Objective: To provide a set of diagnostic criteria for early-stage hip osteoarthritis (OA) in primary care, using signs and symptoms monitored over 2 years in individuals with hip pain and/or stiffness. Additionally, the study aimed to see whether these factors were additive to factors based on baseline signs and symptoms only.
Methods: Data of the 543 persons with 735 symptomatic hips were collected from the prospective Cohort Hip and Cohort Knee cohort study. Using data from 5 to 10 years of follow-up, 24 experts (13 general practitioners, 11 secondary care physicians (6 rheumatologists and 5 orthopaedic surgeons)) inspected individuals' medical data on the presence of clinically relevant hip OA. Their diagnoses are used as reference standards. Backward selection method was used to provide models using the factors from baseline to 2 years of follow-up. Additionally, new models were combined with previously published models, using same selection method. Area under the curve (AUC) was calculated after each removal of factors in the final combined models.
Results: Radiographic factors and high-sensitive C reactive protein did not end up in any model with change factors only. AUC value (SD) of the final obtained model of change factors was 0.70 (0.01). Adding newly defined factors to previously published models significantly (p<0.0001) increased the AUC value to 0.75 (0.01).
Conclusion: Final diagnostic criteria, consisting only of the factors obtained through history taking and physical examination, were able to detect early-stage hip OA associated with clinically relevant hip OA 5-10 years later, with 'moderate' precision.
{"title":"Two-year clinical follow-up enhances the diagnosis of early-stage hip osteoarthritis: data from check cohort.","authors":"Jos Runhaar, Ömer Özbulut, Margreet Kloppenburg, Maarten Boers, Johannes W J Bijlsma, Sita Bierma-Zeinstra","doi":"10.1136/rmdopen-2024-004208","DOIUrl":"10.1136/rmdopen-2024-004208","url":null,"abstract":"<p><strong>Objective: </strong>To provide a set of diagnostic criteria for early-stage hip osteoarthritis (OA) in primary care, using signs and symptoms monitored over 2 years in individuals with hip pain and/or stiffness. Additionally, the study aimed to see whether these factors were additive to factors based on baseline signs and symptoms only.</p><p><strong>Methods: </strong>Data of the 543 persons with 735 symptomatic hips were collected from the prospective Cohort Hip and Cohort Knee cohort study. Using data from 5 to 10 years of follow-up, 24 experts (13 general practitioners, 11 secondary care physicians (6 rheumatologists and 5 orthopaedic surgeons)) inspected individuals' medical data on the presence of clinically relevant hip OA. Their diagnoses are used as reference standards. Backward selection method was used to provide models using the factors from baseline to 2 years of follow-up. Additionally, new models were combined with previously published models, using same selection method. Area under the curve (AUC) was calculated after each removal of factors in the final combined models.</p><p><strong>Results: </strong>Radiographic factors and high-sensitive C reactive protein did not end up in any model with change factors only. AUC value (SD) of the final obtained model of change factors was 0.70 (0.01). Adding newly defined factors to previously published models significantly (p<0.0001) increased the AUC value to 0.75 (0.01).</p><p><strong>Conclusion: </strong>Final diagnostic criteria, consisting only of the factors obtained through history taking and physical examination, were able to detect early-stage hip OA associated with clinically relevant hip OA 5-10 years later, with 'moderate' precision.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141306669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-11DOI: 10.1136/rmdopen-2024-004294
Giulia Corte, Armin Atzinger, Selahattin Alp Temiz, Rita Noversa de Sousa, Melek Yalcin Mutlu, Verena Schoenau, Maria Gabriella Raimondo, Arnd Kleyer, Torsten Kuwert, Andreas Ramming, David Simon, Michael Sticherling, Christian Schmidkonz, Georg Schett, Filippo Fagni
Objectives: To assess the presence and anatomical distribution of activated fibroblasts in the joints and entheses of patients with psoriasis with arthralgia and to test how fibroblast activation visualised by 68gallium-labelled fibroblast activation protein inhibitor-04 (68Ga-FAPI-04)-positron emission tomography (PET)/CT correlates with clinical tenderness, musculoskeletal ultrasound findings and progression to psoriatic arthritis (PsA).
Methods: We conducted a prospective cohort study in patients with psoriasis and arthralgia who underwent clinical and ultrasound evaluation and whole-body PET/CT imaging with 68Ga-FAPI-04. 68Ga-FAPI-04 uptake at synovial and entheseal sites was assessed by maximal standardised uptake values (SUVmax) and PET/CT Joint Index (JI); logistic regression models were used to investigate its correlation with clinical and ultrasound findings. Survival analyses were performed on patients with at least 6 months of follow-up.
Results: 36 patients with psoriasis were enrolled. 68Ga-FAPI-04 uptake was found in 318 (7.9%) joints and 369 (7.3%) entheses in 29 (80.6%) participants, with a mean SUVmax (SD) of 3.2 (1.8) for joints and 2.9 (1.6) for entheses. Large joints and the lower limbs were predominantly affected. A significant positive relationship was found between 68Ga-FAPI-04-PET/CT signal intensity and the 68 tender joint count (SUVmax: p<0.001; PET/CT-JI: p<0.001) and tender entheses count (SUVmax: p<0.001; PET/CT-JI: p=0.002). No correlations were found with ultrasound findings (SUVmax: p=0.969; PET/CT-JI: p=0.720). Patients with relevant synovio-entheseal 68Ga-FAPI-04 uptake showed a statistically significant higher risk of developing PsA (p=0.02), independent of ultrasound findings.
Conclusions: Patients with psoriasis presenting with arthralgia show localised signs of resident tissue activation in joints and entheses, which are associated with higher risk of developing PsA.
{"title":"Anatomical pattern of entheseal and synovial fibroblast activation in patients with psoriasis and its risk of developing psoriatic arthritis.","authors":"Giulia Corte, Armin Atzinger, Selahattin Alp Temiz, Rita Noversa de Sousa, Melek Yalcin Mutlu, Verena Schoenau, Maria Gabriella Raimondo, Arnd Kleyer, Torsten Kuwert, Andreas Ramming, David Simon, Michael Sticherling, Christian Schmidkonz, Georg Schett, Filippo Fagni","doi":"10.1136/rmdopen-2024-004294","DOIUrl":"10.1136/rmdopen-2024-004294","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the presence and anatomical distribution of activated fibroblasts in the joints and entheses of patients with psoriasis with arthralgia and to test how fibroblast activation visualised by <sup>68</sup>gallium-labelled fibroblast activation protein inhibitor-04 (<sup>68</sup>Ga-FAPI-04)-positron emission tomography (PET)/CT correlates with clinical tenderness, musculoskeletal ultrasound findings and progression to psoriatic arthritis (PsA).</p><p><strong>Methods: </strong>We conducted a prospective cohort study in patients with psoriasis and arthralgia who underwent clinical and ultrasound evaluation and whole-body PET/CT imaging with <sup>68</sup>Ga-FAPI-04. <sup>68</sup>Ga-FAPI-04 uptake at synovial and entheseal sites was assessed by maximal standardised uptake values (SUVmax) and PET/CT Joint Index (JI); logistic regression models were used to investigate its correlation with clinical and ultrasound findings. Survival analyses were performed on patients with at least 6 months of follow-up.</p><p><strong>Results: </strong>36 patients with psoriasis were enrolled. <sup>68</sup>Ga-FAPI-04 uptake was found in 318 (7.9%) joints and 369 (7.3%) entheses in 29 (80.6%) participants, with a mean SUVmax (SD) of 3.2 (1.8) for joints and 2.9 (1.6) for entheses. Large joints and the lower limbs were predominantly affected. A significant positive relationship was found between <sup>68</sup>Ga-FAPI-04-PET/CT signal intensity and the 68 tender joint count (SUVmax: p<0.001; PET/CT-JI: p<0.001) and tender entheses count (SUVmax: p<0.001; PET/CT-JI: p=0.002). No correlations were found with ultrasound findings (SUVmax: p=0.969; PET/CT-JI: p=0.720). Patients with relevant synovio-entheseal <sup>68</sup>Ga-FAPI-04 uptake showed a statistically significant higher risk of developing PsA (p=0.02), independent of ultrasound findings.</p><p><strong>Conclusions: </strong>Patients with psoriasis presenting with arthralgia show localised signs of resident tissue activation in joints and entheses, which are associated with higher risk of developing PsA.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168197/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141306744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-08DOI: 10.1136/rmdopen-2023-003504
Marco Garrido-Cumbrera, Denis Poddubnyy, Fernando Sommerfleck, Christine Bundy, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Laura Christen, Victoria Navarro-Compan
Background: The International Map of Axial Spondyloarthritis (IMAS) is a global initiative aimed to assess the impact and burden of axial spondyloarthritis (axSpA) and identify the unmet needs from the patient's perspective.
Method: IMAS is a collaboration between the Axial Spondyloarthritis International Federation (ASIF), the University of Seville, Novartis Pharma AG and steered by a scientific committee. IMAS collected information through an online cross-sectional survey (2017-2022) from unselected patients with axSpA from Europe, Asia, North America, Latin America and Africa who completed a comprehensive questionnaire containing over 120 items.
Results: 5557 patients with axSpA participated in IMAS. Mean age was 43.9 ±12.8 years, 55.4% were female, 46.2% had a university education and 51.0% were employed. The mean diagnostic delay was 7.4 ±9.0 years (median: 4.0), and the mean symptom duration was 17.1 ±13.3 years. 75.0% of patients had active disease (Bath Ankylosing Spondylitis Disease Activity Index ≥4), and 59.4% reported poor mental health (12-item General Health Questionnaire ≥3). In the year before the survey, patients had visited primary care physicians 4.6 times and the rheumatologist 3.6 times. 78.6% had taken non-steroidal anti-inflammatory drug ever, 48.8% biological disease-modifying antirheumatic drugs and 43.6% conventional synthetic disease-modifying antirheumatic drugs. Patients's greatest fear was disease progression (55.9%), while the greatest hope was to be able to relieve pain (54.2%).
Conclusions: IMAS shows the global profile of patients with axSpA, highlighting unmet needs, lengthy delays in diagnosis and high burden of disease in patients with axSpA worldwide. This global information will enable more detailed investigations to obtain evidence on the critical issues that matter to patients around the world to improve their care and quality of life.
{"title":"International Map of Axial Spondyloarthritis (IMAS): results from the perspective of 5557 patients from 27 countries around the globe.","authors":"Marco Garrido-Cumbrera, Denis Poddubnyy, Fernando Sommerfleck, Christine Bundy, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Laura Christen, Victoria Navarro-Compan","doi":"10.1136/rmdopen-2023-003504","DOIUrl":"10.1136/rmdopen-2023-003504","url":null,"abstract":"<p><strong>Background: </strong>The International Map of Axial Spondyloarthritis (IMAS) is a global initiative aimed to assess the impact and burden of axial spondyloarthritis (axSpA) and identify the unmet needs from the patient's perspective.</p><p><strong>Method: </strong>IMAS is a collaboration between the Axial Spondyloarthritis International Federation (ASIF), the University of Seville, Novartis Pharma AG and steered by a scientific committee. IMAS collected information through an online cross-sectional survey (2017-2022) from unselected patients with axSpA from Europe, Asia, North America, Latin America and Africa who completed a comprehensive questionnaire containing over 120 items.</p><p><strong>Results: </strong>5557 patients with axSpA participated in IMAS. Mean age was 43.9 ±12.8 years, 55.4% were female, 46.2% had a university education and 51.0% were employed. The mean diagnostic delay was 7.4 ±9.0 years (median: 4.0), and the mean symptom duration was 17.1 ±13.3 years. 75.0% of patients had active disease (Bath Ankylosing Spondylitis Disease Activity Index ≥4), and 59.4% reported poor mental health (12-item General Health Questionnaire ≥3). In the year before the survey, patients had visited primary care physicians 4.6 times and the rheumatologist 3.6 times. 78.6% had taken non-steroidal anti-inflammatory drug ever, 48.8% biological disease-modifying antirheumatic drugs and 43.6% conventional synthetic disease-modifying antirheumatic drugs. Patients's greatest fear was disease progression (55.9%), while the greatest hope was to be able to relieve pain (54.2%).</p><p><strong>Conclusions: </strong>IMAS shows the global profile of patients with axSpA, highlighting unmet needs, lengthy delays in diagnosis and high burden of disease in patients with axSpA worldwide. This global information will enable more detailed investigations to obtain evidence on the critical issues that matter to patients around the world to improve their care and quality of life.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-08DOI: 10.1136/rmdopen-2024-004199
Manouk de Hooge, Roos Stal, Alexandre Sepriano, Xenofon Baraliakos, Monique Reijnierse, Jürgen Braun, Désirée van der Heijde, Floris A van Gaalen, Sofia Ramiro
Objectives: To assess the association of posterior element (PE) and facet joint (FJ) inflammation with subsequent new FJ ankylosis (FJA) on MRI, in patients with radiographic axial spondyloarthritis (r-axSpA).
Methods: Patients from the Sensitive Imaging in Ankylosing Spondylitis cohort, inclusion criteria r-axSpA and ≥1 radiographic spinal syndesmophyte, were studied. MRI of the full spinal was performed at baseline, 1 and 2 years. PE/FJ inflammatory lesions and FJA were assessed per vertebral unit (VU) level by three readers. With multilevel time-lagged autoregressive generalised estimated equations, the association between PE/FJ inflammation and the subsequent development of FJA was investigated, taking the reader and VU levels into account.
Results: Out of the 58 patients with at least 2 reader scores available, mean age 49 (SD 10) years, 84% men, 59% had baseline PE inflammation, 24% had FJ inflammation and 26% had FJA. PE inflammation was more prevalent in the lower thoracic spine and FJ inflammation in the upper thoracic spine. VU with PE or FJ inflammation showed subsequent new FJA in two and one VU levels, respectively. The probability of developing FJA doubled with prior FJ inflammation. In multilevel analysis, FJ inflammation was associated with subsequent FJA (OR=3.8, 95% CI: 1.5 to 9.8), while no association was found between PE inflammation and new FJA (OR=1.2 (0.6-2.4)).
Conclusions: FJ inflammation is rare in severe r-axSpA, but when present, the likelihood of developing subsequent FJA is over three times higher compared with FJ without inflammation. This finding contributes to the understanding of the relationship between inflammation and ankylosis at the same anatomical location in patients with axSpA.
目的评估放射性轴性脊柱关节炎(r-axSpA)患者的后部关节(PE)和面关节(FJ)炎症与随后在磁共振成像上出现的新的面关节强直(FJA)之间的关联:研究对象为强直性脊柱炎敏感成像队列中的患者,纳入标准为r-axSpA和≥1个放射性脊柱综合征。在基线、1 年和 2 年时进行了全脊柱 MRI 检查。PE/FJ炎性病变和FJA由三位阅读者按椎体单位(VU)水平进行评估。通过多层次时滞自回归广义估计方程,研究了PE/FJ炎症与随后发生的FJA之间的关联,同时考虑到了阅读器和VU水平:在至少有两个读者评分的 58 名患者中,平均年龄 49 岁(SD 10),84% 为男性,59% 有基线 PE 炎症,24% 有 FJ 炎症,26% 有 FJA。PE 炎症多发于下胸椎,FJ 炎症多发于上胸椎。有 PE 或 FJ 炎症的 VU 随后分别在两个和一个 VU 级别出现新的 FJA。先前患有 FJ 炎症的 VU 发生 FJA 的概率增加了一倍。在多层次分析中,FJ炎症与随后的FJA有关(OR=3.8,95% CI:1.5-9.8),而PE炎症与新的FJA之间没有关联(OR=1.2(0.6-2.4)):结论:FJ炎症在重度r-axSpA中很少见,但一旦出现,与无炎症的FJ相比,继发FJA的可能性要高出三倍多。这一发现有助于了解轴性SpA患者同一解剖位置的炎症与强直之间的关系。
{"title":"Inflammation in the posterior elements, in particular the facet joint and facet joint ankylosis over 2-year follow-up in radiographic axial spondyloarthritis.","authors":"Manouk de Hooge, Roos Stal, Alexandre Sepriano, Xenofon Baraliakos, Monique Reijnierse, Jürgen Braun, Désirée van der Heijde, Floris A van Gaalen, Sofia Ramiro","doi":"10.1136/rmdopen-2024-004199","DOIUrl":"10.1136/rmdopen-2024-004199","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the association of posterior element (PE) and facet joint (FJ) inflammation with subsequent new FJ ankylosis (FJA) on MRI, in patients with radiographic axial spondyloarthritis (r-axSpA).</p><p><strong>Methods: </strong>Patients from the Sensitive Imaging in Ankylosing Spondylitis cohort, inclusion criteria r-axSpA and ≥1 radiographic spinal syndesmophyte, were studied. MRI of the full spinal was performed at baseline, 1 and 2 years. PE/FJ inflammatory lesions and FJA were assessed per vertebral unit (VU) level by three readers. With multilevel time-lagged autoregressive generalised estimated equations, the association between PE/FJ inflammation and the subsequent development of FJA was investigated, taking the reader and VU levels into account.</p><p><strong>Results: </strong>Out of the 58 patients with at least 2 reader scores available, mean age 49 (SD 10) years, 84% men, 59% had baseline PE inflammation, 24% had FJ inflammation and 26% had FJA. PE inflammation was more prevalent in the lower thoracic spine and FJ inflammation in the upper thoracic spine. VU with PE or FJ inflammation showed subsequent new FJA in two and one VU levels, respectively. The probability of developing FJA doubled with prior FJ inflammation. In multilevel analysis, FJ inflammation was associated with subsequent FJA (OR=3.8, 95% CI: 1.5 to 9.8), while no association was found between PE inflammation and new FJA (OR=1.2 (0.6-2.4)).</p><p><strong>Conclusions: </strong>FJ inflammation is rare in severe r-axSpA, but when present, the likelihood of developing subsequent FJA is over three times higher compared with FJ without inflammation. This finding contributes to the understanding of the relationship between inflammation and ankylosis at the same anatomical location in patients with axSpA.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-04DOI: 10.1136/rmdopen-2024-004202
Maureen Dubreuil, Victoria Navarro-Compán, Annelies Boonen, Karl Gaffney, Lianne S Gensler, Christine de la Loge, Thomas Vaux, Carmen Fleurinck, Ute Massow, Vanessa Taieb, Michael F Mørup, Atul Deodhar, Martin Rudwaleit
Objective: To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2.
Methods: Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL).
Results: At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo.
Conclusion: Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52.
{"title":"Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies.","authors":"Maureen Dubreuil, Victoria Navarro-Compán, Annelies Boonen, Karl Gaffney, Lianne S Gensler, Christine de la Loge, Thomas Vaux, Carmen Fleurinck, Ute Massow, Vanessa Taieb, Michael F Mørup, Atul Deodhar, Martin Rudwaleit","doi":"10.1136/rmdopen-2024-004202","DOIUrl":"10.1136/rmdopen-2024-004202","url":null,"abstract":"<p><strong>Objective: </strong>To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2.</p><p><strong>Methods: </strong>Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL).</p><p><strong>Results: </strong>At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo.</p><p><strong>Conclusion: </strong>Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52.</p><p><strong>Trial registration numbers: </strong>NCT03928704; NCT03928743.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141248458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}